TUTAMEN DE MEXICO, LLC

FDA Device Registration & Listing · Tijuana Baja California, MX · Registration 3013591868

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013591868
FEI Number
3013591868
Entity Name
TUTAMEN DE MEXICO, LLC
City/State/Country
Tijuana Baja California, MX
Establishment Address
Calle 9 sur ext 101 ciudad industrial, Baja Maq el Aguila, Tijuana Baja California 22444, MX
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Tutamen de Mexico, LLC (Owner Number: 10055035)
Owner / Operator Contact Address
Aguila Coronada #19181, Baja Maq el Aguila, Tijuana, MX-BCN 22215, MX
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

PBM Therapy iWalk3 - Hands Free Crutch TUT FACE SHIELD Richmar Hydratherm Smartbrace Apex Liquid Medicine Dispenser UltraSling Quadrant

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2023-04-10
IPR Crutch Physical Medicine Class 1 890.3150 2020-07-22
ITS Joint, Hip, External Brace Physical Medicine Class 1 890.3475 2019-03-22
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2020-04-24
IRQ Unit, Heating, Powered Physical Medicine Class 1 890.5950 2024-02-15
ITW Joint, Ankle, External Brace Physical Medicine Class 1 890.3475 2021-01-25
ION Exerciser, Non-Measuring Physical Medicine Class 1 890.5370 2019-06-07
ITQ Joint, Knee, External Brace Physical Medicine Class 1 890.3475 2018-03-09
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2022-10-25
ILI Sling, Arm Physical Medicine Class 1 890.3640 2017-07-07
ILZ Accessories, Traction Physical Medicine Class 1 890.5925 2020-09-23

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Tutamen de Mexico, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013591868. Last updated year: 2026. Please use registration number 3013591868 when referencing this establishment in official correspondence.
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